Flexible maxillo-mandibular fixation device

ABSTRACT

A system for achieving maxillo-mandibular fixation includes a bone fixation device including a bone fixation body formed from a plurality of links. The links define corresponding crests and valleys so as to impart flexibility into the bone fixation body. Thus, the bone fixation body can be aligned with the dental arch of the mandible and maxilla as necessary, and subsequently fastened to the underlying bone. Each bone fixation device includes at least one securement location on the fixation body that can attach to a securement device, such that the securement device fixes or stabilizes the mandible and the maxilla with respect to each other.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/326,901, filed on Jul. 9, 2014, the disclosure of which is herebyincorporated by reference as if set forth in its entirety herein.

BACKGROUND

The fixation or stabilization of the upper and lower dental occlusalarches to each other is known as intermaxillary fixation (IMF) and alsoknown as maxillo-mandibular fixation (MMF). MMF has historically beenincluded in the treatment of fracture, orthognathic, and reconstructivejaw procedures. Various methods for achieving MMF are known in the art.

Circumdental wiring techniques include metallic wires that are placedaround one or more teeth and then twisted in various methods to securethe teeth. Wires or twisted pairs of wires can form cables and betwisted to each other to stabilize the dental arch. Loops formed onmandibular teeth can be wired to loops formed around maxillary teeth inorder to stabilize the top dentition to the bottom dentition. While thematerials used in circumdental wiring are relatively inexpensive, thetechnique is tedious and time consuming. The wires also can interferewith dental hygiene.

Another conventional technique includes arch bars that are used incombination with wiring. Specifically, a metal bar is preformed tocorrespond with the curvature of the dental arch. Wires are then passedaround the teeth and over the bar, and then twisted to the bar. This isperformed at multiple locations along the bar to provide stabilityaround the dental arch. Since the bars typically have bent or formedhooks on them for securing wire, the hooks can be used for wiring theupper arch bar to the lower arch bar. Elastic bands can also be used tofix the upper arch bar to the lower arch bar. Unfortunately, thistechnique is time consuming, and interferes with dental hygiene.Further, passing wires around the teeth and over the bar creates a riskthat the surgeon may puncture his or her surgical glove, therebypotentially facilitating the spread of disease.

Another conventional technique involves placing a plurality of screws inthe mandible or maxilla in regions that avoid the tooth roots. The screwheads may contain through holes. The screw head serves as an area aroundwhich wires may be wrapped, and the holes can facilitate the passage ofwire through the heads. Thus, wires may be secured to adjoining sets ofscrews to provide MMF. This system unfortunately suffers from a lack ofoverall structural stability which can be necessary, for instance, whenaddressing fractures around the teeth.

SUMMARY

In accordance with one embodiment, a bone fixation system includes firstand second bone fixation devices. The first bone fixation deviceincludes a first fixation body having a first securement location and afirst attachment location. The first bone fixation device also includesa bone fastener configured to be embedded into an underlying first boneat the first attachment location, thereby attaching the first fixationbody to the first bone. The second bone fixation device includes asecond fixation body having a second securement location and a secondattachment location. The second bone fixation device also includes abone fastener configured to be embedded into an underlying second boneat the second attachment location, thereby attaching the second fixationbody to the second bone. The first and second securement locations areconfigured to engage with a securement device that secures the first andsecond bone fixation devices with respect to each other.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description, isbetter understood when read in conjunction with the appended drawings.For the purpose of illustrating the maxillo-mandibular fixation deviceand related method thereof, there is shown in the drawings exemplaryembodiments; however, the maxillo-mandibular fixation device and relatedmethods are not limited to the specific embodiments and methodsdisclosed. Like reference numerals refer to corresponding partsthroughout the several embodiments of the drawings, in which:

FIG. 1 is a perspective view of a maxillo-mandibular fixation systemincluding a pair of fixation devices attached to the maxilla andmandible of a patient, and secured together;

FIG. 2A is a perspective view of a bone fixation body constructed inaccordance with one example embodiment in a neutral configuration;

FIG. 2B is a sectional elevation view of the fixation device illustratedin FIG. 2A taken along the line 2B-2B;

FIG. 3A is a front view of the fixation device illustrated in FIG. 2A inthe neutral configuration;

FIG. 3B is a front view of the fixation device illustrated in FIG. 3A,but shown in a compressed configuration;

FIG. 3C is a front elevation view of the fixation device illustrated inFIG. 3A, but shown in an expanded configuration;

FIG. 4 is a sectional elevation view of the fixation device illustratedin FIG. 2A, taken along line 4-4;

FIG. 5 is a sectional elevation view of the fixation device similar toFIG. 4, but illustrated in accordance with an alternative embodiment;

FIG. 6 is a sectional elevation view of the mandibular fixation deviceillustrated in FIG. 2A, implanted in the manner illustrated in FIG. 1,and taken along line 6-6 of FIG. 1 to show the fixation of the device tothe mandible;

FIG. 7 is a front elevation view of a bone fixation body constructed inaccordance with an alternative embodiment;

FIG. 8 is a front elevation view of a bone fixation body constructed inaccordance with another alternative embodiment;

FIG. 9 is a front elevation view of a bone fixation body constructed inaccordance with another alternative embodiment;

FIG. 10 is a perspective view of the maxillo-mandibular fixation systemas illustrated in FIG. 1, but wherein the fixation devices define anoffset in accordance with another embodiment;

FIG. 11 is a front view of a bone fixation body of the fixation systemillustrated in FIG. 10;

FIG. 12 is a perspective view of the bone fixation body of the fixationsystem illustrated in FIG. 11, shown in a relaxed configuration;

FIG. 13 is a sectional elevation view of the fixation device illustratedin FIG. 12, taken along line 13-13;

FIG. 14 is a sectional elevation view of the fixation device illustratedin FIG. 12, implanted in the manner illustrated in FIG. 10, and takenalong line 14-14 of FIG. 10 to show the fixation of the device tounderlying bone;

FIG. 15A is a perspective view of a bone fixation body similar to thebone fixation body illustrated in FIG. 12, but constructed in accordancewith an alternative embodiment;

FIG. 15B is a perspective view of a bone fixation body similar to thebone fixation body illustrated in FIG. 15A, but constructed inaccordance with an alternative embodiment;

FIG. 16A is a perspective view of a fastener constructed in accordancewith another embodiment;

FIG. 16B is another perspective view of the fastener illustrated in FIG.16A;

FIG. 16C is a side elevation view of the fastener illustrated in FIG.16A;

FIG. 17A is an exploded sectional side elevation view showing insertionof the fixation device illustrated in FIG. 14 into a screw hole of thefixation body illustrated in FIG. 12;

FIG. 17B is a sectional side elevation view showing the fixation deviceillustrated in FIG. 14 inserted into a screw hole of the fixation bodyillustrated in FIG. 12;

FIG. 17C is a sectional side elevation view showing the fixation deviceillustrated in FIG. 14 inserted into a screw hole of the fixation bodyillustrated in FIG. 12 in accordance with another embodiment;

FIG. 18A is a perspective view of the maxillo-mandibular fixation systemas illustrated in FIG. 10, but wherein the fasteners are constructed asillustrated in FIG. 16A;

FIG. 18B is an enlarged perspective view of a portion of themaxillo-mandibular fixation system illustrated in FIG. 18A;

FIG. 19A is a perspective view showing insertion of a fixation memberconstructed in accordance with an alternative embodiment into a screwhole of the fixation body illustrated in FIG. 12;

FIG. 19B is a sectional side elevation view showing the fixation deviceillustrated in FIG. 19A inserted into a screw hole of the fixation bodyillustrated in FIG. 12; and

FIG. 20 is a perspective view of a portion of the maxillo-mandibularfixation system as illustrated in FIG. 10, but wherein the fasteners areconstructed as illustrated in FIG. 19A.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

For convenience, the same or equivalent elements in the variousembodiments illustrated in the drawings have been identified with thesame reference numerals. Certain terminology is used in the followingdescription for convenience only and is not limiting. The words “right”,“left”, “upper,” and “lower” designate directions in the drawings towhich reference is made. The words “inward”, “inwardly”, “outward”,“outwardly,” “upward,” “upwardly,” “downward,” and “downwardly” refer todirections toward and away from the geometric center of the deviceand/or designated parts thereof. The terminology intended to benon-limiting includes the above-listed words, derivatives thereof andwords of similar import.

Referring initially to FIGS. 1 and 2A-B, a bone fixation, orstabilization, system 20 is configured to provide maxillo-mandibularfixation (MMF) for assisting the repairing of an injury to themaxillo-mandibular region. For instance, when a jaw bone, such as amandible 24 and/or maxilla 26, is fractured at a fracture location 37,it is desirable to stabilize the broken bone segments by fixing orstabilizing the maxilla and the mandible relative to each other. Thefixation system 20 includes a pair of fixation devices 22 and 22′,including bone fixation bodies 29 and 29′, one or more fasteners 35 thatattach each fixation body 29 and 29′ to underlying bone, and one or moresecurement devices 23 that connect, or secure the fixation devices 22and 22′ to each other. The fasteners 35 can include bone screws or anyother type of fastener suitable for attaching the fixation bodies 29 and29′ to underlying bone. Thus, the fixation devices 22 and 22′ can besecured to the mandible 24 and the maxilla 26, respectively, of apatient. The suitable securement device 23 can secure the fixationbodies 29 and 29′ to each other, thereby fixing the mandible 24 and themaxilla 26 with respect to relative movement.

Specifically, each fixation body 29 and 29′ includes a respectiveplurality of flexible links 31 and 31′ extending between a respectiveplurality of longitudinally spaced interfaces 33 and 33′. Thepluralities of flexible links 31 and 31′ extend upwardly and downwardlyin an alternating pattern between the interfaces 33 and 33′, therebydefining respective pluralities of valleys 30 and 30′ and crests 32 and32′ between opposed ends of the fixation bodies 29 and 29′. Theinterfaces 33 and 33′ defined at respective valleys 30 and 30′ andcrests 32 and 32′ can be configured as securement or attachmentlocations. In the illustrated configuration, the interfaces 33 and 33′at the valleys 30 and 30′ are configured as attachment locations havingapertures 34 and 34′, respectively. The apertures 34 and 34′ can beconfigured to receive the fasteners 35. For example, the apertures 34and 34′ of the illustrated configuration are threaded so as to providebone fixation holes such as screw holes that receive fasteners 35 in theform of bone screws. Accordingly, the valleys 30 and 30′ are configuredas attachment locations that can be attached to underlying bone, forinstance via the bone screws. The interfaces 33 and 33′ at the crests 32and 32′ are configured as connection, or securement locations which canbe secured to each other to in turn secure the fixation devices 22 and22′ with respect to each other. In the illustrated configuration, theinterfaces 33 and 33′ at the crests 32 and 32′ are defined as securementlocations having tangs 36 and 36′ that extend outwardly from the crests32 and 32′ in a direction generally towards and in between theimmediately adjacent valleys 30 and 30′, respectively. The tangs 36 and36′ can be configured to receive a securement device, for instance thesecurement device 23, so as to secure the tangs 36 and 36′ to eachother. The securement device 23 can be provided as a suitable wire,elastic band, or any other alternative securement apparatus as desired.

The mandibular and maxillo fixation devices 22 and 22′ can beidentically or substantially identically constructed from a bonefixation device 40 (see FIG. 2A), and oriented as desired when implantedinto the mandible 24 and maxilla 26 of a patient to provide the fixationdevices 22 and 22′. Thus, the vertical orientations of the fixationdevices 22 and 22′ are inverted with respect to each other in theillustrated configuration. In particular, the mandibular fixation device22 is oriented such that the plurality of crests 32 are positioned abovethe plurality of valleys 30, and the maxillo fixation device 22′ isoriented such that the plurality of crests 32′ is positioned below theplurality of valleys 30′. The maxillo-mandibular fixation system 20 willnow be described with reference to the bone fixation device 40 asillustrated in FIG. 2A.

The bone fixation device 40 is illustrated as oriented in a verticalplane defined by a longitudinal direction “L” and transverse direction“T” that is perpendicular to the longitudinal direction, and has athickness in a lateral direction “A” that is perpendicular to thelongitudinal and transverse directions L and T, respectively. The bonefixation device 40 is elongate along the longitudinal direction L beforethe fixation device 40 is curved, bent, or otherwise configured to alignwith, for instance, the mandible or maxilla prior to implantation. Thus,while the description of the bone fixation device 40 is made withreference to the illustrated configuration of the fixation device 40,the description applies equally to orientations achieved when thefixation device 40 is configured for implantation, for instance, in themaxilla or mandible of a patient.

Unless otherwise specified herein, the terms “lateral,” “longitudinal,”and “transverse” are used to describe the orthogonal directionalcomponents of the bone fixation device 40 and its components asillustrated in FIG. 2A. The terms “inner,” “outer,” and derivativesthereof with respect to a specified directional component are usedherein with respect to a given apparatus to refer to directions alongthe directional component toward and away from the center of theapparatus, respectively.

It should be appreciated that while the longitudinal and transversedirections are illustrated as extending along a vertical plane, and thatthe lateral direction is illustrated as extending along a horizontalplane, that the planes that encompass the various directions may differduring use, depending, for instance, on the desired orientation of thebone fixation device 40 when implanted in a patient. Accordingly, whilecertain directional terms are used herein to describe the bone fixationdevice 40 as illustrated merely for the purposes of clarity andconvenience, it should appreciated that these orientations may changeduring use.

Therefore, while the bone fixation device 40 is described with respectto an orientation such that its base (i.e., its valleys) is disposedbelow its crest (i.e., its crests), it can be subsequently oriented asdesired (for instance with the base disposed above the crest whenproviding the maxillo fixation device 22′) when implanted in thepatient. It should thus be understood that while the bone fixationdevice 40 is described in its illustrated orientation with reference toimplantation in the mandible 24, it can alternatively be implanted inthe maxilla 26 or any other desired bone structures that are to be fixedrelative to each other.

With continuing reference to FIG. 2A, the bone fixation device 40includes a flexible bone fixation body 42, which can also be referred toas a fixation plate or a fixation body, and a plurality of fasteners 44configured to attach the fixation body 42 to underlying bone. Thefixation body 42 is illustrated as defining opposed first and secondlongitudinally outer ends 43 and 45, respectively, and opposed inner andouter lateral surfaces 57 and 59. The inner surface 57 faces the gumsurrounding the bone structure to which the fixation body 42 isattached, and thus also faces the bone structure, and the outer surface59 faces a direction opposite the inner surface 57. The fixation body 42includes a plurality of sequential links 46A-E that can be integrallyconnected as illustrated, or can alternatively be discreetly attached toeach other. The links 46A and 46E define outer links, while the links46B-D define inner links disposed between the outer links 46A and 46E.In one embodiment, the fixation body 42 is formed by wire electricaldischarge machining (wire EDM or waterjet machining), though the bodycan be formed from any alternative fabrication process. The fixationbodies 42 and 42′ (see FIGS. 8-9) can be constructed from any suitablebiocompatible material including but not limited to commercially puretitanium, titanium alloy such as TAN, stainless steel, reinforcedplastics, polymers such as polyether ether ketone (PEEK) or PE, and thelike.

As illustrated, the fixation body 42 includes five links 46A-E, thoughany number of links can be used such that reliable fixation can beachieved to a patient's mandible or maxilla, such as three links, fourlinks, or five links. Referring to FIG. 2B, the links 46A-E have arectangular cross-section that is elongate in the vertical plane definedby the transverse T and longitudinal L directions. It should beappreciated that the links 46A can define any cross-sectional shape asdesired, such as square, or any suitable alternative shape.Specifically, the links 46A-E include opposed elongate edges 47 andminor edges 49. The elongate edges 47 can have any length as desired,such as about 1 mm while the minor edges 49 can have any length asdesired, such as about 0.6 mm. The links 46A-E can define a lateralthickness as desired, such as approximately 0.6 mm in accordance withone embodiment. Of course, it may be desirable to eliminate sharpcorners or edges that could cause injury to surrounding tissue whenimplanted in a patient. The size and shape of the links 46 impartflexibility to the fixation body 42, thereby allowing the fixation body42 to assume multiple sizes, and also allowing for variable positioningof the fixation device 40 when implanted in the patient. In this regard,it should be appreciated that the links 46A-E can alternatively defineany suitable alternative geometric size and shape as desired. One ormore of the links 46A-E can be similarly or identically or substantiallyidentically constructed, and will now be described with reference to thelink 46B.

In particular, referring again to FIG. 2A, the link 46B includes a pairof opposed first and second side members 48 and 50. Each side memberdefines respective longitudinally inwardly curved upper ends 52 and 54and opposed longitudinally outwardly curved lower ends 56 and 58. Theupper ends 52 and 54 of the side members 48 and 50 of the link 46B arejoined at a first interface 53, so as to form a crest 51 of the fixationbody 42. The crest 51 is continuously curved about a laterally extendingaxis, such that the crest 51 presents a convex surface with respect to adownwardly directed view of the top of the fixation body 42. Of course,it should be appreciated that the crest 51 could assume any alternativeshape as defined by the upper ends 52 and 54 of the side members 48 and50, or as defined by a separate structure that joins the upper ends 52and 54, either directly or indirectly. For instance, a portion up to allof at least one or more up to all of the crests 51 can be flat.

The side members 48 and 50 are longitudinally spaced from each other,and extend linearly so as to flare longitudinally outward from eachother along a downward direction from their respective upper ends 52 and54 to their lower ends 56 and 58 in the illustrated embodiment. Thus,the first side member 48 flares longitudinally outward toward the firstouter end 43 of the fixation body 42 in a downward direction along theside member 48. Likewise, the second side member 50 flareslongitudinally outward toward the second outer end 45 of the body in adownward direction along the side member 50. In the illustratedembodiment, the side members 48 and 50 flare equally outward withrespect to a transverse midline TM of the link 46B at a desired angle θanywhere between 0° and 90°, for instance between 0° and 45°, such asapproximately 14°.

The lower end 56 of the first side member 48 of the link 46B isconnected to the lower end 58 of the side member 50 of the adjacent link46A at a second interface 53 to form a valley 60 of the fixation body42, and the lower end 58 of the side member 50 of the link 46B isconnected to the lower end 56 of the side member 48 of the adjacent link46C at a third interface 53 to likewise form another valley 60 of thefixation body 42. The valleys 60 are continuously curved about alaterally extending axis, such that the valley presents a convex surfacewith respect to an upwardly directed view of the bottom of the fixationbody 42. Of course, it should be appreciated that the valleys couldassume any alternative shape as defined by the lower ends 56 and 58 ofthe side members 48 and 50, or as defined by a separate structure thatjoins the lower ends 56 and 58 of adjacent links, either directly orindirectly. For instance, a portion up to all of at least one or more upto all of the valleys 60 can be flat. The side members 48 and 50 of eachlink are integrally connected to the complementary side members of theadjacent links at the interfaces 53, though they could alternatively bediscreetly attached to each other at the interfaces 53. Furthermore, theside members 48 and 50 can assume any size and shape as desired thatconnects the crest 51 to the valleys 60, either directly or indirectly.

The fixation body 42 can define any desired longitudinal distance, orwidth W between adjacent valleys 60, and therefore between adjacentcrests 51, such as approximately 20 mm, and any desired transverseheight H between the lower edge of the valley 60 and the upper edge ofthe crest 51 along the transverse direction T, such as approximately17.6 mm. The fixation body 42 can be configured such that a spatialrelationship is defined between the respective crests 51 and/or valleys60. For example, the spatial relationship can be defined such that thewidth W between each of the crests 51 and the width W between each ofthe valleys 60 is uniform throughout the fixation body 42, asillustrated. Alternatively, the spatial relationship can be defined withtwo or more crests 51 separated by different widths W, two or morevalleys 60 separated by different widths W, or any combination thereof.Of course spatial relationships with respect to the height H between thecrests 51 and the valleys 60 can also be defined. The side members 48and 50 can be flat, curved, or otherwise shaped as desired between theinterconnected crests 51 and valleys 60. Further, it should beappreciated that the height H of each of the links can be the same eachother. Alternatively, the height H of one or more of the links can bedifferent than one or more up to all of the links. Further, the width Wcan be constant along the fixation body 42 when the fixation body 42 isin a neutral configuration. Alternatively, the width W can vary alongthe fixation body 42 when the fixation body 42 is in the neutralconfiguration.

It should be appreciated that although the links 46A-E of theillustrated configuration are all the same size and shape, that one ormore, up to all of the links 46A-E of the fixation body 42 can havedifferent sizes and/or shapes, for example having different widths W,heights H, or any combination thereof. It should further be appreciatedthat the links 46A-E need not all have the same cross-section, asdefined between the elongate edges 47 and the minor edges 49. Forexample, it may be desirable to configure one or more of the links 46A-Ewith different lateral thicknesses, for instance to control thedeformation characteristics of particular links when the fixation body42 is flexed inwardly or outwardly in the longitudinal direction L, orotherwise shaped prior to implantation in a patient, as described inmore detail below. Furthermore, the cross section within an individuallink can be varied along one or more portions between its respectiveadjacent valleys 60.

It should be appreciated that the links 46A-E define an undulatingfixation body 42 shaped in a wave-form having wave segments that areproportional in number to the number of links 46. While five links 46A-Eare illustrated, the fixation body 42 can include any number of links46A-E as desired. Each link 46A-E is illustrated as defining a crest 51of the wavelike structure, and a portion of a valley 60 of one or moreadjacent wavelike structures. It should also be appreciated that thelongitudinal widths W and transverse heights H can vary between adjacentcrests and valleys. For instance, one or more of the crests 51 can havea height H greater or lesser than that of one or both of the immediatelyadjacent crests.

The side member 48 of the outer link 46A disposed at the first end 43 ofthe fixation body 42 terminates at its lower end 56, while the sidemember 50 of the outer link 46E disposed at the second end 45 of thefixation body 42 terminates at its lower end 58. Alternatively, itshould be appreciated that a half-link could be disposed at the opposedouter ends 43 and 45, such that each half-link would terminate at theirrespective upper ends 52 and 54, or at any alternative location alongtheir lengths as desired. In the illustrated embodiment, the lower end56 of the side member 48 of the outer link 46A and the lower end 58 ofthe side member 50 of the outer link 46E terminate at respective boneattachment locations 70, as will be described in more detail below.

The fixation body 42 includes a plurality of bone attachment locations70 that facilitate attachment of the fixation body to the underlyingbone. For instance, as described above, the fixation body 42 can beattached to an underlying mandible or maxilla, or any alternative bonestructure, such that a bone fracture is disposed between the opposedouter ends 43 and 45 of the fixation body 42. Accordingly, in theinstance of mandibular or maxillo fixation, when a pair of fixationbodies 42 are secured to each other in the manner described above withrespect to FIG. 1, the broken bone segments are relatively immobilizedto facilitate healing.

In the illustrated embodiment, the bone attachment locations 70 areprovided as screw holes 72 extending laterally through the fixation body42 at the respective valleys 60, though one or more alternativelyconfigured attachment locations can be provided in any suitable mannerso as to facilitate attachment of the fixation body 42 to underlyingbone. The screw holes 72 can be sized to threadedly receivecorresponding fasteners 44, provided in one embodiment as bone screws74. Specifically, referring to FIG. 6, the fixation body 42 includes abeveled inner surface 76 that defines each screw hole 72, and is sizedand shaped to receive a correspondingly beveled outer surface 78 of ascrew head 80. The beveled surface 76 is positioned such that the screwhead 80 does not protrude outwardly from the fixation body 42 when fullyseated in the screw hole 72. As illustrated, the screw head 80 is flushwith the outer surface 59 of the fixation body 42, though the screw head80 could alternatively be inwardly recessed or slightly outwardlyprotruding with respect to the outer surface 59 of the fixation body 42.

Of course, the screw hole 72 could assume one of numerousconfigurations, such that the inner surface 76 can be beveled straight,or rounded at any desired radius, for instance approximately 3.6 mm.Alternatively still, the inner surface 76 need not be beveled, and canextend laterally in a direction parallel to the outer surface of thescrew head 80. As another example, while the inner surface 76 isillustrated as smooth and flat, the inner surface 76 could alternativelybe threaded to threadedly engage corresponding threads of the screw head80, such that the screw 74 would be self-locking within the screw hole72. It should also be appreciated that the bone screws 74 can beself-drilling, or could alternatively be insertable into a pre-drilledhole as appreciated by one having ordinary skill in the art. Thefixation device 40 can further include a collar that surrounds the screwhole 72 at the inner surface 57 of the fixation body 42, such that thecollar would be disposed between the fixation body 42 and the underlyingbone structure. The collar would thus provide a stand-off that spacesthe fixation body 42 from the patient's gum when the bone screws 74 arefully inserted into the underlying bone.

As described above, the links 46A-E are constructed so as to impart aflexibility to the fixation body 42. Specifically, the fixation body canbend about a transverse axis to conform generally with dental arches ofpatients of different sizes and shapes, thereby allowing the bone screws74 to be inserted into the screw holes 72 and screwed into an underlyingmandible or maxilla, as illustrated in FIG. 1. Furthermore, referring toFIGS. 3A-C, the links 46A-E can allow the fixation body 42 to flexlongitudinally.

For instance, FIGS. 2A and 3A illustrate the fixation body 42 in aninitial relaxed, or neutral configuration, whereby the fixation body isin its as-manufactured configuration prior to inward or outward flexingalong the longitudinal direction L. In the neutral configuration, thefixation body 42 can define any longitudinal distance LI as desiredbetween the opposed longitudinally outermost edges, such asapproximately 100 mm.

However, as shown in FIG. 3B, a longitudinally inwardly directed forcecan be applied to one or more, including all, of the links 46, therebycompressing the crests 51 and/or valleys 60 and achieving a reducedlongitudinal length LR of the fixation body 42 to a distance less thanthe initial distance LI, as desired. The fixation body 42 can beconfigured such that when the length of the fixation body 42 is adjustedby longitudinal compression, the longitudinal distance, or spacingbetween the crests 51 and/or valleys 60 (i.e., the width W (FIG. 2A)between adjacent crests 51 and/or valleys 60) in the compressedconfiguration of the fixation body 42 is preserved with respect to therelaxed or neutral configuration of the fixation body 42. In other wordsthe spacing, or width W between adjacent crests 51 and/or valleys 60 ofthe fixation body 42 will be smaller after the longitudinal compression,but the crests 51 and/or valleys 60 can maintain their spatialrelationship; for instance the crests 51 can still be spaced apartequally as they were in the neutral configuration, and the and valleys60 can also be spaced apart equally as they were in the neutralconfiguration.

Additionally, as shown in FIG. 3C, a longitudinally outwardly directedforce can be applied to one or more, up to all, of the links 46, therebyextending the crests 51 and/or valleys 60 and achieving an extended, orexpanded longitudinal length LE of the fixation body 42 to a distancegreater than the initial distance LI, as desired. The fixation body 42can be configured such that when the length of the fixation body 42 isadjusted by longitudinal expansion, the longitudinal distance, orspacing between the crests 51 and/or valleys 60 (i.e., the width Wbetween adjacent crests 51 and/or valleys 60) in the expandedconfiguration of the fixation body 42 is preserved with respect to theneutral configuration of the fixation body 42. In other words thespacing, or width W between adjacent crests 51 and/or valleys 60 of thefixation body 42 will be greater after the longitudinal expansion, butthe crests 51 and/or valleys 60 can maintain their spatial relationship;for instance the crests 51 can still be spaced apart equally as theywere in the neutral configuration, and the and valleys 60 can also bespaced apart equally as they were in the neutral configuration. Itshould be appreciated that the fixation body 42 can be configured suchthat the transverse height H between the crests 51 and/or valleys 60after the fixation body 42 is compressed and/or expanded is similarlypreserved with respect to the neutral configuration of the fixation body42.

It should therefore be appreciated that the bone attachment locations 70can remain aligned with the underlying bone even as the fixation body 42is flexed longitudinally inward and/or outward. Furthermore, the boneattachment locations 70 can be aligned or substantially aligned witheach other along a longitudinal axis LA even as the fixation body 42 isflexed longitudinally inward and outward. In one embodiment, thefixation body 42 can stretch or compress lengthwise longitudinally anamount between 5% and 50% with respect to its length in the relaxedposition, for instance between 10% and 40%, and more particularlybetween 20% and 30%, and more particularly still about 23%. The fixationbody 42 can further stretch or compress height-wise transversely by anysuitable percentage with respect to its height in the relaxed position,such as between 1% and 25%, for instance between 5% and 15%, and moreparticularly about 11%. It should be appreciated that when the body 42is stretched longitudinally, the body 42 tends to shrink or compresstransversely, and vice versa. Furthermore, when the body 42 iscompressed longitudinally, the body 42 tends to stretch transversely,and vice versa.

Thus, the configuration of the fixation body 42 can be adjusted in situwhile implanting the fixation device 40 in the patient. For instance,the fixation body 42 can be sized and configured as desired based on thesize of the underlying bone segments to be fixed. Additionally, thefixation body 42 can be sized and configured to place the securementlocations in a desired position prior to fastening the fixation body 42to underlying bone. Furthermore, the side members 48 and 50 allow thefixation body 42 to be bent or otherwise configured in the verticalplane as well, for instance, when aligning the fixation body 42 withunderlying bone. While the fixation body 42 is flexible, the continuitybetween adjacent links 46 provides sufficient stiffness when thefixation device 40 is affixed to underlying bone and attached to acomplementary fixation device in a fixation system.

It should be appreciated that the fixation body 42 can be constructed soas to allow the fixation body 42 to extend and/or compress as desired.In this regard, the fixation body 42 includes at least two side membersthat are longitudinally spaced from each other by an interface 53 thatcan expand and compress in response to expansive and compressive forces.As illustrated, the interfaces 53 are curved surfaces (e.g., the crests51 and valleys 60) whose curvature can be increased and reduced throughflexing, though the interfaces 53 can alternatively include angledconnections between the side members 48 and 50. The compressive andexpansive deformation of the fixation body 42 can be plastic, or canalternatively be elastic such that the deformed shape is retained whenthe fixation body 42 is attached to the underlying bone at theattachment locations 70. Of course, the height of the fixation body 42may increase slightly when the fixation body 42 is compressed, and maydecrease slightly when the fixation body 42 is extended.

Referring again to FIG. 2A and also to FIG. 4, the fixation device 42further includes a plurality of connection, or securement locations 82configured to facilitate connecting, or securing together a pair offixation devices 40 that are inversely oriented, for instance whenimplanted in a mandible and maxilla, respectively. In the illustratedconfiguration, the securement locations 82 are disposed at thelongitudinal midpoint, or apex of the crest 51 of each of the links46A-E. However, it should be appreciated that alternatively, thesecurement locations 82 can be disposed anywhere on the fixation body 42as desired. It should be appreciated that each crest 51 can support arespective securement location 82. Alternatively, one or more of thecrests 51 can be devoid of a securement location, such that one or morecrests 51 can be disposed between adjacent securement locations 82.Alternatively still, one or more up to all of the links can include oneor more securement locations 82 as desired. Alternatively oradditionally, one or more up to all of the links can include one or moreattachment locations 70 as desired. The securement locations 82 can beconfigured to allow a securement member, such as the securement device23 described above with respect to FIG. 1, to connect a pair of fixationbodies 42 to each other so as to restrict relative movement of the boneunderlying the connected fixation bodies 42.

The securement locations 82 are provided in the illustrated embodimentas tangs 84 extending down from the apex of each crest 51 of thefixation body 42. Otherwise stated, the tangs 84 extend in a generallytransverse direction from the crest 51 toward a longitudinal axis LAthat extends through the screw holes 72. One or more, up to all, of thetangs 84 can also include longitudinally or laterally extending segmentsas well, if desired. For instance, in the illustrated embodiment, eachof the tangs 84 includes a first segment 86 that extends downward alongthe transverse direction T from the transverse inner edge of the apex ofthe crest 51. A second, or spacer, segment 88 extends in the downwarddirection and outward along the lateral direction A from the lower endof the first segment 86. A third segment 90 extends down in thetransverse direction T from the lower end of the spacer segment 88.

Thus, a securement device, such as the securement device 23 describedabove, can engage the lower surface of the spacer segment 88 andlaterally inner surface of the third segment 90 when fixing orstabilizing a pair of mandibular and maxillo fixation bodies 42 to eachother. Alternatively or additionally, the securement device 23 canengage the laterally inner surface of the first segment 86 and thelaterally outer surface of the crest 51. For instance, a wire can bewrapped around the tang 84 and/or link 46. Alternatively oradditionally, an elastic band can be seated at one end between the tang84 and the crest 51. Because securement devices 23 can be attached atmultiple locations along the length of the fixation body 42, theresulting forces associated with coupling the securement devices 23 to acomplementary fixation body 42 distributes the resulting forcessubstantially equally across the length of the fixation body 42.

Alternatively, referring now to FIG. 5, one or more, up to all, of thetangs 84′ can include a single segment 86′ constructed similarly withrespect to the segment 86, thus extending vertically down from the crest51 in the manner describe above. Thus the tang 84′ does not include anylateral or longitudinal directional components. The securement device 23can be wrapped around the segment 86′ in the case of a wire, forinstance, or can be seated between the segment 86′ and the crest 51 inthe case of an elastic band. Alternatively still, it should beappreciated that the securement locations 82 can include the crest 51itself, without any tangs 84 or other additional structure. Forinstance, a plurality of elastic bands could be slid along the wavelikeform of the fixation body 42 to locations at respective crests 51 priorto implantation of the fixation body 42 into underlying bone.Alternatively, a wire could be wrapped around the crests 51 of opposedfixation bodies 51 prior to or after implantation of the fixation bodies42. Alternatively still, the securement location 82 could be provided asan aperture extending laterally through the links 46A-E, for instance attheir crests 51.

The fixation device 40 was illustrated and described above in accordancewith one embodiment, it being appreciated that numerous alternativeembodiments are contemplated.

For instance, referring to now FIG. 7, the fixation body can includeauxiliary links, and can alternatively or additionally includesecurement locations that are positioned differently than the securementlocations 82 described above. As illustrated in FIG. 7, the fixationbody 42 can include auxiliary links 92 connected between adjacent links46. The auxiliary links 92 can extend between the first and second sidemembers 48 and 50 of adjacent links 46 at any respective desiredlocations along the first and second side members 48 and 50,respectively. For instance, in the illustrated embodiment, the auxiliarylinks 92 extend between the first and second side members 48 and 50 atlocations proximate to, or at, the respective upper ends 52 and 54 ofthe first and second side members 48 and 50. The auxiliary links 92 areillustrated as extending transversely upward and inward from the sidemembers 48 and 50 toward an auxiliary crest 94 that is shapedsubstantially as described above with respect to the crests 51. Thus,the auxiliary crest 94 presents a convex surface with respect to adownwardly directed view of the top of the fixation body 42, though theauxiliary crest 94 could assume any alternative shape as desired. Theauxiliary crests 94 allow the auxiliary links 92 to expand and contractas described above with respect to FIGS. 3A-C, though the auxiliarylinks 92 can be configured to add an amount of stiffness to the fixationbody 42 with respect to the fixation body 42 as illustrated in FIG. 2Awithout the auxiliary links 92. The auxiliary crests 94 can bepositioned longitudinally midway between the crests 51 of the links46A-E, which can be referred to as “primary” links 46A-E when thefixation body 42 includes the auxiliary links 92.

As illustrated in FIG. 7, one or more, up to all of the auxiliary links92 can be configured as auxiliary securement locations 96, constructeddifferently or as described above with respect to the securementlocations 82. The auxiliary securement locations 96 can be providedanywhere along the auxiliary links 92, such as at the apexes of theauxiliary crests 94. Thus, for instance, the auxiliary securementlocations 96 can be configured to allow a securement member, such as thesecurement device 23 described above with respect to FIG. 1, to connecta pair of fixation bodies 42 to each other so as to restrict relativemovement of the bone underlying the connected fixation bodies 42. In theillustrated embodiment, the auxiliary securement locations 96 areprovided as tangs 98 that extend from the auxiliary crests 94 asdescribed above with respect to tangs 84 and 84′ extending fromrespective crests 51. It should be appreciated that the auxiliarysecurement locations 96 can be provided in addition to the securementlocations 82, as an alternative to the securement locations 82, or thatany combination of the securement locations 82 and/or the auxiliarysecurement locations 96 can be provided as desired.

Referring now to FIG. 8, a portion of a fixation body 42′ is illustratedas including a plurality of links 46′ that are shaped differently withrespect to the straight side members 48 and 50 of the links 46A-Eillustrated in FIG. 2A. For instance, as illustrated, the side members48′ and 50′ of a given link 46′ can be longitudinally inwardly curvedtoward each other from their respective lower end 56′ and 58′ near theirrespective valleys 60′ in a transverse upward direction along the sidemembers 48′ and 50′ toward the crest 51′, then longitudinally curvedoutwardly away from each other in a continuing transverse upwarddirection, and finally longitudinally curved inwardly toward each otheragain at the respective upper ends 52′ and 54′ of the side members 48′and 50′ near the crest 51′. It should be appreciated that theillustrated curvature of the side members 48′ and 50′ is an example ofalternative curvature for the links 46′, and that the side members 48′and 50′ can be configured with any other alternative curvature asdesired. It should further be appreciated that the fixation body 42 of afixation device 40 can be configured entirely of links 46′, therebyproviding a fixation body 42′, or can be configured with any combinationof the links 46′ and the links 46 as described above with reference toFIGS. 2A-B, as desired. The curved side members 48′ and 50′ can beconfigured to allow the fixation body 42′ to flex in the transversedirection. Accordingly, when a pair of fixation devices 40 havingfixation bodies 42′ are secured to each other as illustrated in FIG. 1,the fixation devices 40 can flex toward each other in response to theforces applied by the securement device 23. It should be appreciatedthat the fixation body 42′ can further include auxiliary links and/orauxiliary securement locations as described above with reference to FIG.7.

Furthermore, as described above, the lower end 56 of the side member 48of the outer link 46A and the lower end 58 of the side member 50 of theouter link 46E terminate at respective bone attachment locations 70, asillustrated in FIG. 2A. Accordingly, as illustrated in FIG. 2A, the bonefixation device 40 can terminate at outermost bone attachment locations70. Alternatively, as illustrated in FIG. 9, in which the bone fixationdevice 40′ includes three links 46A′-C′, the outermost links 46A′ and46C′ are attached to outermost securement locations 82′ via arms 50″ and48″, respectively. The arms 50″ and 48″ extend longitudinally outwardlyfrom the ends 43′ and 45′ of the fixation body 42′, between lower armends 56″ and 58″ and upper arm ends 52″ and 54″, respectively. However,it should be appreciated that the bone fixation device 40′ asillustrated in FIG. 9 could be constructed as described above withreference to FIG. 2A, or any alternative embodiments described herein.Thus, the outermost securement locations 82′ are disposed longitudinallyoutward with respect to the outermost bone attachment locations 70′. Asillustrated, the fixation body 42′ can include four bone attachmentlocations 70′ as illustrated, or any alternative number of boneattachment locations 70′ as desired. The outermost securement locations82′ can be disposed above, below, or at a transverse heightsubstantially equal to that of the other securement locations 82′ of thebone fixation device 40′. In the illustrated embodiment, the outermostsecurement locations 82′ are disposed at a transverse height below thatof the other securement locations 82′ of the bone fixation device 40′.

The outermost securement locations 82′ can be provided as hooks 83′extending in the longitudinal-transverse plane, or any alternative planeas desired, for example from the upper arm ends 52″ and 54″ of the arms50″ and 48″, respectively. Thus, a securement device, such as device 23described above, can engage the hooks 83′ of opposed fixation bodies 42′when fixing or securing a pair of mandibular and maxillo fixation bodies42′ to each other. In this regard, it should be appreciated that any ofthe securement locations described herein could comprise hooks or anyalternative structure suitable for connecting, or securing a pair offixation devices as described above.

Referring now to FIG. 10, the bone fixation system 20 can include thefirst and second bone fixation devices 22 and 22′ that can beidentically or substantially identically constructed from the bonefixation device 40 (see FIG. 12) substantially as described above.Additionally, the first and second bone fixation bodies 22 and 22′ canbe configured such that the valleys 30 are offset with respect to thecrests 32, and the valleys 30′ are offset from the crests 32′. As aresult, when the first bone fixation body 22 is attached to the mandible24, the valleys 30 are disposed closer to the mandible 24 than adistance that the crests 32 are spaced from the mandible. Similarly, thevalleys 30′ are disposed closer to the maxilla 26 than a distance thatthe crests 32′ are spaced from the maxilla.

Referring now also to FIGS. 11-14, the bone fixation device 40 includesthe flexible bone fixation body 42 and the plurality of fasteners 44(see also FIG. 2A) configured to attach the fixation body 42 tounderlying bone, as described above. The bone fixation body 42 includesa plurality of links 46 that are spaced from each other along a firstdirection. It is appreciated that when the bone fixation body 42 is in afirst configuration, such as a neutral or relaxed configuration, thefirst direction can be the straight longitudinal direction L. When thebone fixation body 42 is in the flexed configuration (see FIG. 10), thefirst direction can be a curved direction 40 that fits the bone fixationbody 42 to the underlying bone.

The links 46, in combination, define the plurality of securementlocations 82, the plurality of attachment locations 70 that are offsetfrom the securement locations 82 along a second direction substantiallyperpendicular to the first direction. For instance, when the bonefixation body 42 is in the first configuration, the second direction canbe defined by the transverse direction T. The bone fixation body 42 canfurther include a plurality of side members 48 and 50 that extend fromrespective ones of the securement locations 82 to respective adjacentones of the attachment locations 70. It is appreciated that the sidemembers 38 and 50, the securement locations 82, and the attachmentlocations 70 of the fixation body 42 can all be monolithic with eachother, thereby defining a one-piece structure. As described above, thesecurement locations 82 and the attachment locations 70 can bealternatingly arranged along the fixation body 42.

The side members 48 and 50 can each define a respective offset region 71that offsets the securement locations 82 from the attachment locations70 along a third direction that is substantially perpendicular to eachof the first and second directions. When the bone fixation body 42 is inthe first configuration, the third direction can be defined by thelateral direction A. In one example the side members 48 and 50 candefine crests 51 that each supports a respective one of the securementlocations 82, as described above. The side members 48 and 50 can furtherdefine valleys 60 that each defines a respective one of the attachmentlocations 70 as described above. Further, the offset region 71 can causethe valleys 60 to be offset from the crests 51 along the thirddirection. It is appreciated that the first, second, and thirddirections may be substantially perpendicular to each other. Forinstance, when the fixation body 42 is in a bent or flexedconfiguration, the first, second, and third directions may not beprecisely perpendicular to each other.

Further, as described above, the fasteners 44 are configured to bedriven or embedded into underlying bone at respective ones of theattachment locations 70, thereby attaching the fixation body 42 to theunderlying bone. The securement locations 82 are configured to engagewith respective ones of the securement devices 23 so as to secure thefixation device 42 to complementary securement members of an identicalsecond fixation device. 40. For instance, the first and second fixationdevices 40 can be arranged as illustrated in FIG. 10 with respect to thefirst and second fixation devices 22 and 22′.

Because the securement locations 82 are outwardly offset from theattachment locations 70 along the third direction, when the fasteners 44are embedded into the underlying bone 24 at the respective ones of theattachment locations 70 (see FIG. 14), the attachment locations 70 aredisposed closer to the underlying bone along the third direction than adistance that the securement locations 82 are spaced from the underlyingbone along the third direction. Accordingly, the securement devices 23and securement locations 82 can be spaced from soft tissue thatsurrounds the underlying bone.

As described above, for instance with respect to FIGS. 1, 2, and 12, thebone fixation body 42 can include a plurality of securement locations 82and a plurality of attachment locations 70. For instance, the securementlocations 82 can be disposed at respective ones of the crests 51, andthe attachment locations 70 can be disposed at respective ones of thevalleys 60. It is recognized, however, that the securement locations 82and the attachment locations 70 can alternatively be located at anysuitable location of the bone fixation body 42, and can be present inany arrangement as desired. For instance, the securement locations 82and the attachment locations 70 can be alternatingly arranged along thelongitudinal direction L. For instance, each crest 51 can support arespective one of the securement locations 82, and each valley 60 cansupport a respective one of the attachment locations 70. Alternatively,one or more of the crests 51 can be devoid of a securement location 82.Similarly, one or more of the valleys 60 can be device of an attachmentlocation 70.

For instance, referring now to FIG. 15A, all of the crests 51 can bedevoid of securement locations 82 and attachment locations 70. Rather,one or more of the valleys 60 can support the securement locations 82,and one or more of the valleys 60 can support the attachment locations70 as described above. Thus, both the attachment locations 70 and thesecurement locations 82 can be supported at the valleys 60. Accordingly,at least some up to all of the attachment locations 70 and thesecurement locations 82 can be aligned with each other with respect tothe longitudinal direction L. For instance, the attachment locations 70and the securement locations 82 can be alternatingly arranged along thelongitudinal direction L. It should be appreciated, however, that theattachment locations 70 and the securement locations 82 can be disposedin any suitable alternative arrangement as desired. The free ends of thetangs 84 of the securement locations 82 can extend out from the valleys60 along a direction from the crests 51 toward the valleys 60 so as tofacilitation attachment of the securement members 23 to the bonefixation body 42. Thus, the tangs 84 can extend out from the valleys 60in a direction opposite the opposed bone fixation body 42. The bonefixation body 42 can further include a plurality of offset regions 71between the valleys 60 that support the attachment locations 70 and thevalleys 60 that support the securement locations 82. The offset regions71 can cause the securement locations 82 to be spaced outward withrespect to the attachment locations 70 along the lateral direction A asdescribed above with respect to FIGS. 10-13. The offset regions 71 canbe defined by the side walls 48 and 50 that extend from the valleys 60that support the attachment locations 70, though it should beappreciated that the offset regions 71 can be defined by the side walls48 and 50 that extend from the valleys 60 that support the securementlocations 82.

Alternatively, as illustrated in FIG. 15B, all of the valleys 60 can bedevoid of securement locations 82 and attachment locations 70. Rather,one or more of the of the crests 51 can support the securement locations82, and one or more others of the crests 51 can support the attachmentlocations 70 as described above. Thus, both the attachment locations 70and the securement locations 82 can be supported at the crests 51.Accordingly, at least some up to all of the attachment locations 70 andthe securement locations 82 can be aligned with each other with respectto the longitudinal direction L. For instance, the attachment locations70 and the securement locations 82 can be alternatingly arranged alongthe longitudinal direction L. It should be appreciated, however, thatthe attachment locations 70 and the securement locations 82 can bedisposed in any suitable alternative arrangement as desired. The freeends of the tangs 84 of the securement locations 82 can extend out fromthe crests 51 along a direction from the crests 51 toward the valleys 60so as to facilitation attachment of the securement members 23 to thebone fixation body 42. Thus, the tangs 84 can extend out from thevalleys 60 in a direction opposite the opposed bone fixation body 42.The bone fixation body 42 can further include a plurality of offsetregions 71 between the crests 51 that support the attachment locations70 and the crests 51 that support the securement locations 82. Theoffset regions 71 can cause the securement locations 82 to be spacedoutward with respect to the attachment locations 70 along the lateraldirection A as described above with respect to FIGS. 10-13. The offsetregions 71 can be defined by the side walls 48 and 50 that extend fromthe crests 51 that support the attachment locations 70, though it shouldbe appreciated that the offset regions 71 can be defined by the sidewalls 48 and 50 that extend from the crests 51 that support thesecurement locations 82. It should be appreciated, of course that eachof the crests 51 and valleys 60 can support both attachment locations 70and securement locations 82 in any suitable arrangement as desired.

The bone attachment locations 70 can be configured as screw holes 72that extend along the lateral direction A through the fixation body 42at the respective valleys 60. The screw holes 72 can be sized tothreadedly receive corresponding fasteners 44, provided in oneembodiment as bone screws 74. The fixation body 42 can include aplurality of inner surfaces 76 that define respective ones of the screwholes 72. The inner surfaces 76 can be sized and shaped to receive thecorresponding outer screw surface 78 of the screw head 80. For instance,the inner surfaces 76 and the outer screw surfaces 78 can be beveled orotherwise tapered or shaped as desired. In accordance with oneembodiment the inner surfaces 76 are positioned such that the screw head80 does not protrude outwardly from the fixation body 42 when fullyseated in the screw hole 72. For instance, the screw head 80 can beflush with the outer surface 59 of the fixation body 42, though thescrew head 80 could alternatively be inwardly recessed or slightlyoutwardly protruding with respect to the outer surface 59 of thefixation body 42 as desired. As described above, at least a portion ofthe inner surfaces 76 can be threaded so as to threadedly mate with thecorresponding outer surface 78 of the respective screw head.Alternatively or additionally, at least a portion of the inner surfaces76 can be unthreaded such that the screw head 80 compresses the fixationbody 42 toward the underlying bone as the fastener 44 is driven throughthe screw hole 72 and into the bone.

Of course, the screw hole 72 could assume one of numerousconfigurations, such that the inner surface 76 can be beveled straight,or rounded at any desired radius, for instance approximately 3.6 mm.Alternatively still, the inner surface 76 need not be beveled, and canextend laterally in a direction parallel to the outer surface of thescrew head 80. As illustrated in FIG. 6, at least one or more up to allof the inner surfaces 76 can be smooth and flat, and the correspondingouter surfaces 78 can likewise be smooth. Accordingly, when the threadedshaft 75 of the screw 74, which extends out from the head 80, is driventhrough the screw hole 72 and into the underlying bone, for instancebone 24, the outer surface 78 can compress against the inner surface 76,thereby compressing the attachment locations 70, and thus the bonefixation body 42, against the underlying bone. Alternatively, asillustrated in FIG. 14, the inner and outer surfaces 76 and 78 can bethreaded, such that the threaded heads 80 are configured to threadedlymate with the attachment locations 70. Accordingly, when the threadedshaft 75 is driven through the screw hole 72 and into the underlyingbone, for instance bone 24, the outer surface 78 can threadedly matewith the inner surface 76, thereby securing the attachment locations 70,to the underlying bone without compressing the attachment locationsagainst the underlying bone.

Referring now to FIGS. 15A-17B, the fasteners 44 can be constructed inaccordance with any suitable embodiment as desired. For instance, one ormore of the fasteners 44 up to all of the fasteners 44 can include abody 100 that includes a shaft 108 and a stop member 110. The body 100defines a proximal end 100 a and a distal end 100 b opposite theproximal end 100 a and spaced from the distal end 100 b in a proximaldirection. The shaft 108, and thus the body 100, is elongate along acentral axis 102 from the proximal end 100 a to the opposed distal end100 b. The fasteners 44 can further include a head 104 that extends outfrom the proximal end 100 a at least along a radial direction that isperpendicular to the central axis 102. The head 104 can also extend outfrom the proximal end 100 a in the proximal direction. The head 104 canbe configured to engage a driving instrument, such as a screwdriver,that, in turn, is configured to apply a torsional force to the fixationmember 44 about the central axis 102. For instance, the head 104 candefine any suitable drive interface 106 that is configured to engage thedriving instrument. The head 104 can define an outer surface 104 a thatfaces generally in the proximal direction, and thus away from the shaft108. The drive interface 106 can be configured as a recess that extendsinto the outer surface 104 a, such as a cruciform, a flat recess, a starshaped socket, a hex-shaped recess, a triangular recess, or any suitablealternatively constructed interface as desired. Alternatively oradditionally, a radially outer surface of the head 104 that facesgenerally away from the central axis 102 can define the drive interfaceas desired.

The shaft 108 can define a proximal shaft end 108 a and a distal shaftend 108 b spaced from the proximal shaft end 108 a along the centralaxis 102 in a distal direction that is opposite the proximal direction.The distal shaft end 108 b can coincide with the distal end 100 b of thebody 100. The distal shaft end 108 b can define a tip, which can includecutting flutes as desired. In one example, the fastener 44 can beself-tapping. At least a portion of an outer surface of the shaft 108can be threaded, such that the shaft 108 can define at least oneexternal helical thread 112. The shaft 108 is sized to be insertedthrough the screw hole 72 and driven into the underlying bone, which canbe the mandible or the maxilla. For instance, the fastener 44 can berotated about the central axis 102 so as to drive the threaded shaft 108into the underlying bone. The stop member 110 extends radially out awayfrom the central axis 102, and is configured to abut the bone fixationbody 42 at the respective attachment location 70, and thus at therespective valley 30. For instance, the stop member 110 can beconfigured to abut the inner surface 76 of the screw hole 72. The stopmember 110 is disposed between the shaft 108 and the head 104 along thecentral axis 102. Accordingly, the body 100 defines a neck 114 that isdisposed between the head 104 and the stop member 110. The neck 114 isrecessed with respect to at least the head 104 along an radially inwarddirection toward the central axis. The neck 114 can be further recessedwith respect to at least a portion up to an entirety of the stop member110 in the radially inward direction. The head 104 can extend radiallyoutward with respect to the stop member 110, the stop member 110 canextend radially outward with respect to the head 104, or the head 104and stop member 110 can extend radially outward the same distance asdesired.

In one example, an outer surface of the stop member 110 can be threaded,such that the stop member 110 defines at least one external helicalthread 116. The stop member 110 can be configured to be inserted intothe screw hole 72, such that the at least one helical thread 116threadedly purchases with the inner surface 76 of the screw hole 72. Thehelical thread 112 of the shaft 108 can define a first pitch, and thehelical thread 116 of the stop member 110 can define a second pitch thatis equal to the first pitch. Accordingly, the stop member 110 canadvance in the screw hole 72 at the same rate that the shaft 108advances in the underlying bone. It should be appreciated that the firstpitch can alternatively be greater than the second pitch, such that theshaft 108 advances in the underlying bone at a rate greater than therate at which the stop member 110 advances in the screw hole 72, therebycreating compression of the bone fixation body 42 against the underlyingbone. In one example, the at least one helical thread 116 of the stopmember 110 can be a double lead thread, or any suitable alternativethread as desired. At least a portion of the outer surface of the stopmember 110 can be tapered in the radially inward direction toward thecentral axis 102 as the outer surface extends in the distal direction.For instance, the outer surface of the stop member 110 can be conical inshape. Likewise, the inner surface 76 of the screw hole 72 can beconical. Accordingly, the stop member 110 can be inserted into the screwhole 72 in the distal direction until abutment between the stop member110 and the inner surface 76 prevents further movement of the fastener44 with respect to the bone fixation body 42 in the distal direction. Itshould be appreciated, as illustrated in FIG. 16A, that the bonefixation body 42 can be placed against the underlying bone 24, forinstance at the attachment location 70. Next, as illustrated in FIG.16B, the shaft 108 can be driven through the screw hole 72 and into theunderlying bone 24 until the stop member 110 threadedly mates with theinner surface 76, thereby fixing the plate body 42 at a location againstthe underlying bone 24. Alternatively, as illustrated in FIG. 16C, theplate body 42, at least the attachment location 70 up to an entirety ofthe plate body 42 can be spaced from the underlying bone 24 when thestop member 120 threadedly mates with the inner surface 76. Thus, atleast a portion of the plate body 42 up to an entirety of the plate body42 can be fixed at a location spaced from the underlying bone 24.

With continuing reference to FIGS. 15A-17, the body 100 can define arecess 101 between the head 104 and the stop member 110. The recess 101can be sized to receive a respective securement device 23 between thehead 104 and the stop member 110. The recess can define a distance alonga direction parallel to the central axis 102 in a range from andincluding approximately 0.2 mm to approximately 6 mm. For instance, therange can be from and including approximately 0.75 mm to approximately 6mm. For example, the distance can be approximately 1 mm. The head 104can define a cross-sectional dimension along a direction perpendicularto the central axis 102 that is in a range from and includingapproximately 2 mm to approximately 9 mm. For instance, head 104 candefine a cross-sectional dimension of approximately 4.5 mm. Thecross-sectional dimension can, in one example, be a diameter. The neck114 can define a cross-sectional dimension along a directionperpendicular to the central axis 102 that is in a range from andincluding approximately 1 mm to approximately 5 mm, such asapproximately 2 mm to approximately 4 mm. In one example, thecross-sectional dimension of the neck 114 can be approximately 2.2 mm.The cross-sectional dimension of the neck 114 can be a diameter in oneexample. It should be appreciated that the above dimensions arepresented by way of example only, and that the dimensions can vary asdesired.

Thus, the head 104 can be spaced from the stop member 110 a distance inthe proximal direction sufficient so as to receive the securement device23. In accordance with one embodiment, the securement device 23 can bewrapped around the neck 114, so as to attach to one or more otherfasteners 44. The securement device 23 can attach to one or more otherfasteners 44 of the respective bone fixation body 42 in the mannerdescribed above. Alternatively or additionally, the securement device 23can attach to one or more other fasteners 44 of the opposed fixationbody 42 in the manner described above. Alternatively or additionallystill, the securement device 23 can attach to one or more securementlocations 82 of the respective fixation body 42 in the manner describedabove. Alternatively still, the securement device 23 can attach to oneor more securement locations 82 of the opposed fixation body 42 in themanner described above. Thus, the neck 114 can be unthreaded and smoothas desired.

Referring now to FIGS. 18A-19, in accordance with another example, thestop member 110 of the fastener 44 can be configured as a shoulder 118that is configured to abut the outer surface 59 of the bone fixationbody 42. For instance, the shoulder 118 can define an outercross-sectional dimension in a select direction perpendicular to thecentral axis 102 that is greater than the diameter of the screw hole 72at the outer surface 59. In one embodiment, the shoulder 118 can definea distal surface 118 a that is configured to face and abut the bonefixation body 42, and an opposed proximal surface 118 b. The distalsurface 118 a can be substantially flat so as to create surface contactwith the outer surface 59 of the bone fixation body 42. It should beappreciated, however, that the distal surface 118 a can define anysuitable size and shape as desired. Thus, during operation, the shaft108 is threadedly driven into the underlying bone until the shoulder 118abuts the outer surface 59 of the bone fixation body 42, such thatfurther insertion of the shaft 108 into the underlying bone causes theshoulder 118 to apply a compressive force to the bone fixation body 42toward the underlying bone.

As described above, the neck 114 is configured to attach to a respectivesecurement device 23, such as a flexible wire, that fixes the fastener44 to one or more other fasteners 44, one or more other securementlocations 82, or a combination of fasteners 44 and securement locations82. For instance, one or more securement devices 23 can otherwise bewrapped around or otherwise extend about the neck 114 as describedabove. Alternatively or additionally, the body 100 of the fastener 44can define a first cross-bore 120 that extends through the neck 114along a first direction perpendicular to the central axis 102. The body100 can further define a second cross-bore 122 that extends through theneck 114 along a second direction that is different than the firstdirection. For instance, the second direction can be perpendicular tothe first direction. Further, the second cross-bore 122 can intersectthe first cross-bore 120. As illustrated in FIG. 19, each of the firstand second cross-bores 120 and 122 can be sized to receive a respectivesecurement device 23 so as to attach the fastener member 4 to one ormore others of the fasteners 44 or to one or more of the securementlocations 82 of the respective bone fixation body 42 or to the opposedbone fixation body as desired, as is described in more detail below.Each of the cross-bores 120 and 122 can receive respective differentsecurement devices 23 or the same securement device 23 that is furthercoupled one or more other bone fixation members 44, or to one or more ofthe securement locations 82 as desired.

It should be appreciated that when the fastener 44 is attached to thebone fixation body 42 such that the stop member 110 is in abutment withthe bone fixation body 42 to prevent further translation of the fastener44 relative to the bone fixation body 42 in the distal direction asdescribed herein, the head 104 can be spaced from the outer surface 59.As described above, the head 104 can be spaced from the soft tissue,such that during bone healing, the head 104 is positioned to reduce orprevent overgrowth of the mucosa. For instance, at least a portion ofthe recess 101 can be disposed between the head 104 and the outersurface 59. When the stop member 110 is disposed in the screw hole 72,the recess can be defined by the head 104 and the outer surface 59. Whenthe stop member 110 abuts the outer surface, the recess 101 can bedisposed between the head 104 and the outer surface 59, and defined bythe head 104 and the stop member 110. In both cases, the head 104 can bespaced from the outer surface 59 by at least a recess, which can includea portion up to an entirety of the recess 101, alone or in combinationwith the stop member 110 that is in abutment with the outer surface 59.As a result, the head 104 is spaced from the soft tissue. Accordingly,during bone healing, the head 104 is positioned to reduce or preventovergrowth of the mucosa. As a result, when the bone fixation system 20is to be removed, the drive interfaces 106 can be exposed to thetechnician so as to facilitate removal of the fasteners 44 from theunderlying bone.

As described above with respect to FIGS. 11-14, the bone fixation body42 defines an offset region 71 at the side members 48 and 50 that spacesthe securement locations 82 from the attachment locations 70 along thethird direction. For example, the as the side members 48 and 50 extendfrom the respective attachment locations 70 to the respective securementlocations 82, the side members extend outward along the third directionat the offset regions. In accordance with one embodiment, the sidemembers 48 and 50 each extend along a respective first plane P1 from theattachment location 70, bend outward away from the first plane along thethird direction to a respective second plane P2 at the offset region 71,and extend from the offset region 71 to the respective securementlocation 82. Thus, the side members 48 can extend along the first planeP1 at a location between the attachment location 70 and the offsetregion 71, and can extend along the second plane P2 at a locationbetween the offset region 71 and the securement location 82. The secondplane P2 can be parallel to the first plane P1, or can be angularlyoffset with respect to the first plane P1 as desired. It is thusappreciated that the crests 51 and the valleys 60 can define respectiveouter surfaces that lie in respective planes that are offset from eachother along the third direction. The respective planes P1 and P2 canfurther be parallel with each other or angularly offset with respect toeach other. Further, while the fixation body 42 can define a firstoffset between the first and second planes P1 and P2, the fixation body42 can define any number of offsets between the first and second planesP1 and P2. Further, while the securement locations 82 can be alignedwith each other along the longitudinal direction L when the fixationbody 42 is in its neutral configuration, one or more up to all of thesecurement locations 82 can alternatively be out of alignment withrespect to one or more up to all other ones of the securement locations82 along the longitudinal direction. For instance, one or more up to allof the securement locations 82 can alternatively be offset with respectto one or more up to all other ones of the securement locations 82 alongone or both of the lateral direction A and the transverse direction T.

As described above, the securement locations 82 can be configured astangs 84 that extend from the respective ones of the crests 51 along thetransverse direction T, such that the tangs 84 extend toward a gapbetween adjacent ones of the valleys 60. It is appreciated that thetangs 84 can extend in other directions as well, as they extend alongthe transverse direction T. As illustrated in FIG. 13, the tangs 84extend from the crests 51 to respective free ends 84 that are offsetwith respect to the respective crests 51 in an outward direction 85 thatis along the third direction. It is appreciated that the securementlocations 82, such as the tangs 84, are offset with respect to theattachment locations 70 in the outward direction 85. Further, the crests51 are offset with respect to the attachment locations, and valleys 60,along the outward direction 85. The tangs 84 can further extend in aninward direction as they extend from the respective crest 51 towardtheir respective free end, at least along a portion of their length. Theinward direction is opposite the outward direction 85, and is also alongthe third direction.

One or more, up to all, of the tangs 84 can also include longitudinallyor laterally extending segments as well, if desired. For instance, inthe illustrated embodiment, each of the tangs 84 can include the firstsegment 86 that extends downward along the transverse direction T fromthe transverse inner edge of the apex of the crest 51. The second, orspacer, segment 88 extends in the downward direction and outward alongthe lateral direction A from the lower end of the first segment 86. Thethird segment 90 can extend down in the transverse direction T from thelower end of the spacer segment 88. As illustrated in FIG. 13, the thirdsegment 90 can further extend inward the lateral direction A, oppositethe outward direction, to a distal end 84 a of the tangs. Accordingly,the distal end 84 a of the tang 84 a can be spaced from the second planeP2 a first distance, and a proximal end of the tang 84 opposite thedistal end 84 a along the length of the tang 84 can be spaced from thesecond plane P2 a second distance greater than the first distance. Thedistal end 84 a can be defined by the third segment 90. Thus, at least aportion up to an entirety of the third segment 90 is offset with respectto the first segment 86 in the outward direction.

As described above, a securement device, such as the securement device23 described above, can engage the lower surface of the spacer segment88 and laterally inner surface of the third segment 90 when fixing orstabilizing a pair of mandibular and maxillo fixation bodies 42 to eachother. Alternatively or additionally, the securement device 23 canengage the laterally inner surface of the first segment 86 and thelaterally outer surface of the crest 51. For instance, a wire can bewrapped around the tang 84 and/or link 46. Alternatively oradditionally, an elastic band can be seated at one end between the tang84 and the crest 51. Because securement devices 23 can be attached atmultiple locations along the length of the fixation body 42, theresulting forces associated with coupling the securement devices 23 to acomplementary fixation body 42 distributes the resulting forcessubstantially equally across the length of the fixation body 42.

Further, as illustrated in FIGS. 17 and 19, a securement device 23, suchas a flexible wire, can be coupled to the neck 114 of a first at leastone fastener 44 that has been driven through the screw hole 72 of afirst fixation body 42 and into a respective underlying bone, such as amandible, and can further be coupled to the neck of a second at leastone fastener 44 that has been driven through the screw hole 72 of asecond opposed fixation body 42′ and into a respective underlying bone,such as a maxilla. The free ends of the wire can be intertwined so as toattach the first and second plates bodies 42 and 42′ to each other. Asillustrated in FIG. 17, the securement device 23 can extend around thenecks 114 of the respective fasteners 44 as described above.Alternatively, as illustrated in FIG. 19, the securement device 23 canextend through one or both of the cross-bores 120 and 122 in the mannerdescribed above. In accordance with one embodiment, the first at leastone fastener 44 of the first fixation body 42 can be configured as apair of fasteners 44. Similarly, the at least one fastener 44 of thesecond fixation body 42′ can be configured as a pair of fasteners 44.Thus, the securement device 23 can extend along the longitudinaldirection L across at least a pair of fasteners 44 of the first fixationbody 42, and can extend along the longitudinal direction L across atleast a pair of fasteners of the second fixation body 42′. The fixationsystem 20 can include as many securement devices 23 as desired. Forinstance, a pair of securement devices 23 can be coupled to the necks114 of the same fasteners 44, such that adjacent securement devices 23of the fixation system 20 can overlap each other and share at least onefastener from each of the first and second fixation bodies 42 and 42′.Alternatively, the adjacent securement devices 23 can be spaced apartfrom each other so that none of the fasteners 44 to which the adjacentsecurement devices 23 are coupled are in common to each other.

Thus, it should be appreciated that fixation bodies can be provided inaccordance with multiple embodiments. Therefore, a kit can be providedthat includes a plurality of fixation devices, or portions thereof,including fixation bodies constructed in accordance with all or aportion of any of the embodiments described herein. For example, the kitcan include one or more fixation bodies 42 or 42′, having differentnumbers of links, different dimensions, such as overall length, linkwidth, height, and lateral thickness, and differently configured links(for instance differently configured side members 48, 48′, 50, and 50′,securement locations 82, 82′, and 96, and/or auxiliary links 92).Therefore, the fixation bodies in a kit can have one or more varyingcharacteristic such as size and/or shape. For instance, a first kit canbe provided having one or more fixation bodies whose components, forinstance the links and/or the securement locations, are of a first sizeor shape, and other fixation bodies whose components are of a secondsize or shape different than the first size or shape. Thus, the kit canaccommodate multiple maxillo-mandibular fixation procedures involvingsubstantial anatomical variability. In one embodiment, each of the bonefixation bodies 42 and 42′ can include at least two attachment locations70 and at least one securement location 82. One or more fixation bodiescan be attached to the mandible, and one or more opposed fixation bodies42′ can be attached to the maxilla.

According to another embodiment, methods are provided for implanting thevarious embodiments of the fixation device 40. Generally, the methodsinclude the steps of adjusting an orientation (e.g., directional orangular) of the fixation device 40 depending on the anatomy of theunderlying bone structure. For instance, a maxillo fixation device willbe vertically inverted with respect a mandibular fixation device. It isto be understood that certain steps of the methods described herein canbe omitted, combined, performed simultaneously, or performed in adifferent order. In this regard, it should be appreciated that themaxillo-mandibular fixation devices of the type described above can beprovided as a kit that is configured to be implemented for the purposesof maxillo-mandibular fixation using the methods described below.

According to one method of providing fixation to a bone or bone segmentsof a mandible, a first fixation device such as the fixation device 40may be adapted by imparting a curvature as desired to correspond to thedental arch. For instance, before or after attaching the fixation body42 to the first and second bone segments, the fixation body 42 can beflexed so as to move one or more of the crests in the lateral directionA with respect to one or more others of the crests and valleys.Alternatively or additionally, the fixation body 42 can be flexed so asto move one or more of the valleys in the lateral direction A withrespect to one or more others of the crests and valleys. Thus, thefixation body 42 can be flexed to conform to the dental arch.Alternatively and additionally, the fixation body 42 can be flexed so asto rotate the bone segments with respect to each other, thereby aligningthe first and second bone segments with each other during fracturereduction. The fixation device 40 can further be extended or compressedin the longitudinal direction and/or the transverse direction to alignthe screw holes 72 with a desired fixation location on the underlyingbone. Thus the configuration of the fixation body 42 may be adapted toachieve the proper shape and fit for a bone fixation.

The fixation body 42 can be implanted by inserting the fasteners 44 intothe underlying bone. For instance, the fasteners 44 can be driventhrough respective ones of the screw holes 72 and into the mandible, inthe manner described above, on opposite sides of the fracture prior. Theplate body 42 can then be flexed and deformed such that respective onesof the side members 48 and 50 are brought toward each other, therebybringing the bone segments on opposite sides of the fracture toward eachother, thus reducing the fracture. The deformed plate body 42 canprovide a compression force that can at least approximate, and in someinstances fully reduce, the fracture. It should thus be appreciated thatthe fracture in the mandible can be approximated or fully reduced beforeor after the fixation body 42 has been attached to the mandible. Whetherthe fracture has been approximated or reduced before or after thefixation body 42 has been attached to the mandible, the deformed platebody 42 can maintain the approximation or reduction. Alternatively oradditionally, securement members 23 can be attached to the fasteners 44in the manner described above at opposite sides of the fracture.Accordingly, the securement members 23, alone or in combination with thedeformed plate body 42, can at least approximate, and in some instancesfully reduce, the fracture. In one embodiment, the fracture can beapproximated or reduced prior to attaching the securement members 23 tothe fixation members 44. Thus, the securement members can maintain thefracture in the approximated or reduced configuration. In anotherembodiment, tension can be induced in the fixation member 44, such thatthe securement members 23 apply a force to the fixation members 44 thatdraws the side walls 48 and 50 toward each other, thereby approximatingor reducing the fracture. It should thus be appreciated in certainexamples that the bone fixation system 20 can reduce or approximate thefracture after fixing the plate body 42 to the underlying bone. Thefracture can thus be approximated or reduced prior to attaching theplate body 42 to the underlying bone, after attaching the plate body tothe underlying bone, for instance by deforming the plate body, and afterthe plate body has been deformed, for instance by inducing tension inthe securement members 23.

Next, a second fixation device 40 can be implanted in a second bonestructure that is to be fixed with respect to the bone structure thatunderlies the first fixation body 40. For instance, a second fixationbody 42 can be implanted into the maxilla in the manner described above,but in an orientation that is vertically inverse with respect to thefirst fixation device 40. It should be appreciated that either the firstand/or second fixation device is implanted over a fracture such that thedevice(s) attach a first bone segment to a second bone segment that hasbeen fractured from the first bone segment.

Once the first and second fixation bodies are implanted into theunderlying bone structure, the securement devices 23 are attached to thesecurement locations of the first and second fixation bodies. In apreferred embodiment, the securement devices 23 are attached between twovertically aligned, or substantially aligned, crests 51. It should beappreciated that the crests 51 of each fixation body can define theshortest vertical distance between the fixation bodies 40, therebyallowing for a securement device 23 that has a short length between thefixation bodies 40.

Thus, referring again to FIGS. 10-19 generally, the method can includethe step of bringing the first and second bone segments, disposed onopposite sides of the fracture, together so as to approximate thefracture. The method can further include the step of placing the bonefixation body 42 over the first and second bone segments, such that atleast a first one of the bone fixation holes 72 is aligned with thefirst bone segment and at least a second one of the bone fixation holes72 is aligned with the second bone segment. The bone fixation body 42can be placed adjacent, for instance against, the mucosa that is thusdisposed between the bone fixation body 42 and the underlying bonesegment. Next, the head of the fastener 44 can be engaged, for instanceby a driving member, and a torsional force can be imparted to the headof the fastener 44 so as to drive the shaft of a fastener 44 through oneof the bone fixation holes 72 and into the aligned bone segment. Thetorsional force can be discontinued after the stop member 110 hasabutted the bone fixation body 42, such that head is spaced from thebone fixation body 42 by the recess 101. It should be appreciated thatthe torsional force can continue to be applied beyond the moment thatthe stop member 110 has abutted the bone fixation body 42, for instance,when compressing the fixation body 42 against the mandible. Next, asecurement device 23 can be inserted into the recess 101, and coupled tothe neck 114. For instance the securement device 23 can be wrappedaround the neck 114. Alternatively, the securement device 23 can beinserted through at least one of the cross-bores 120. As describedabove, the torsional force can be discontinued before the fracture isreduced, such that flexing the bone fixation body 42 can bring the firstand second bone segments together. Alternatively, the fracture can bereduced prior to placing the bone fixation body 42 adjacent theunderlying bone.

The illustrated embodiments are directed to a bone fixation system thatmay be implanted to assist in repairing a fractured bone. The fixationsystem has particular utility as mandibular or maxillo fixation system,which benefits from accurate anatomical shape and fit.

The foregoing description is provided for the purpose of explanation andis not to be construed as limiting the invention. While variousembodiments have been described with reference to preferred embodimentsor preferred methods, it is understood that the words which have beenused herein are words of description and illustration, rather than wordsof limitation. Furthermore, although the embodiments have been describedherein with reference to particular structure, methods, and embodiments,the invention is not intended to be limited to the particulars disclosedherein. Moreover, any of the embodiments described above can incorporateany structures or features of any of the other embodiments describedabove, as desired. Those skilled in the relevant art, having the benefitof the teachings of this specification, may effect numerousmodifications to the invention as described herein, and changes may bemade without departing from the spirit and scope of the invention asdefined by the appended claims.

What is claimed:
 1. A bone fixation body, comprising: a plurality oflinks spaced from each other along a first direction, the links definingrespective crests and valleys offset from each other along a seconddirection that is perpendicular to the first direction, and side membersthat extend between the crests and valleys, such that at least some ofthe links, in combination, define a plurality of securement locationsand a plurality of attachment locations that are spaced from each otherat least along the first direction, wherein the side members each definean offset region that offsets the securement locations from theattachment locations along a third direction that is substantiallyperpendicular to each of the first and second directions, wherein theattachment locations are configured to receive fasteners therethroughand into an underlying jaw bone so as to attach the bone fixation bodyto the underlying jaw bone, and wherein the securement locations areconfigured to engage with a respective securement device that securesthe fixation body to complementary securement locations of a secondfixation body.
 2. The bone fixation body as recited in claim 1, whereinat least some of the attachment locations and the securement locationsare aligned with each other with respect to the first direction.
 3. Thebone fixation body as recited in claim 1, wherein at least some of thesecurement locations and the attachment locations are offset from eachother along the second direction.
 4. The bone fixation body as recitedin claim 1, wherein when the fasteners are inserted into the jaw bone atrespective ones of the attachment locations, the attachment locationsare disposed closer to the jaw bone along the third direction than adistance that the securement locations are spaced from the jaw bonealong the third direction.
 5. The bone fixation body as recited in claim1, wherein as the side members extend from the respective attachmentlocations to the securement locations, the side members each extendalong a respective first plane from the attachment location, bendoutward away from the first plane along the third direction to arespective second plane that is parallel to the first plane, and extendin the second plane to the respective securement locations.
 6. The bonefixation body as recited in claim 1, wherein the side members, thesecurement locations, and the attachment locations are monolithic witheach other.
 7. The bone fixation body as recited in claim 1, wherein thecrests and valleys define respective outer surfaces that lie inrespective planes that are offset from each other along the thirddirection and are parallel with each other.
 8. The bone fixation body asrecited in claim 1, wherein the securement locations comprise tangs thatextend from the respective ones of the crests along a direction from thecrests toward the valleys.
 9. The bone fixation body as recited in claim8, wherein the tangs extend from the crests to respective free ends thatare offset with respect to the respective crests in an outward directionthat is along the third direction.
 10. The bone fixation body as recitedin claim 9, wherein the crests are offset with respect to the valleys inthe outward direction.
 11. The bone fixation body as recited in claim10, wherein the tangs each extend in an inward direction opposite theoutward direction in a direction toward their respective free end. 12.The bone fixation body as recited in claim 1, wherein the bone fixationbody is movable from a first configuration to a flexed configuration,wherein the first direction is a straight longitudinal direction whenthe fixation body is in the first configuration, and the first directionis curved when the fixation body is in the flexed configuration.
 13. Thebone fixation body as recited in claim 1, wherein the attachmentlocations comprise threaded bone fixation holes configured to threadedlymate with threaded heads of the fasteners.
 14. The bone fixation body asrecited in claim 1, wherein the attachment locations define bonefixation holes, and the attachment locations are configured to becompressed against the jaw bone when the fasteners are driven throughthe bone fixation holes and into the jaw bone.
 15. The bone fixationbody as recited in claim 1, wherein the bone fixation body is shaped ina wave-form.
 16. The bone fixation body as recited in claim 1, whereinindividual ones of the crests each support a respective one of thesecurement locations.
 17. The bone fixation body as recited in claim 16,wherein individual ones of the valleys each define a respective one ofthe attachment locations.
 18. The bone fixation body as recited in claim1, wherein one or more of the valleys each support a respective one ofthe securement locations, and one or more of the valleys each define arespective one of the attachment locations.